This invention relates to devices and methods for controlling female incontinence and more particularly to a novel female incontinence control device that employs a magnetically actuatable valve for controlling urinary discharge, and a novel method for controlling urinary discharge.
Urinary incontinence in women is a common condition that can result from a variety of causes including illness, injury or debilitation. An incontinent condition is usually characterized by a weakness or total lack of functioning of the muscles that control expansion and contraction of the urinary sphincter. Thus far there are no known surgical procedures that satisfactorily correct an incontinent condition to the extent that bladder control is substantially restored.
Attempts to ameliorate the condition of incontinence include the use of passive devices such as a collection bag worn by the user to collect urine as it drains from the urethra. One drawback of this arrangement is that the bladder continuously drains into the collection bag without affording the user any control of urinary discharge. A further drawback of this arrangement is that the collection bag must accompany the user and thus inhibits the user's activities. Still another drawback is that the collection bag can provide a path for bacterial infection.
Absorbent pads similar to diapers are another example of a passive remedy for individuals having an incontinent condition. Absorbent pads have disadvantages similar to those described for the collection bag and also require frequent changing.
Other known devices which deal with the problem of female incontinence attempt some form of drainage control and include catheters, draining probes and dilators, such as shown in U.S. Pat. Nos. 4,194,508; 4,198,979 and 4,563,183. Generally such known devices also include an external fluid collection system fastened to a portion of the user's body.
In general, catheters, collection bags and absorbent pads are cumbersome and awkward to use in dealing with incontinence, and are often a source of embarrassment to the user.
Attempts to address such problems as lack of control, bulkiness, discomfort, embarrassment and inhibition of activities have led to the development of valved incontinence control devices, which eliminate the need for external collection systems and allow the user to manually control the flow of urinary fluids from the urinary tract. Examples of such devices are shown in U.S. Pat. Nos. 3,503,400; 3,731,670; 3,939,821 and 4,024,855.
In U.S. Pat .No. 3,503,400, a manually controllable valve is positioned within the urethra near the bladder. The valve is operated by a control cable that passes through the urethra to permit exterior access by the user. Such an arrangement, although permitting positive drainage control, provides a potential path for bacterial infection of the urinary tract, and can also cause discomfort to the user due to the fact that the force on the cable is transferred through the urethra.
In U.S. Pat. No. 3,731,670, a bi-stable magnetic valve member requires a first magnetic actuation from a closed position to an open position and a second magnetic actuation from the closed position back to the open position. Such device, although affording the user some degree of drainage control, is not foolproof. For example, when the valve is subjected to a first actuation into an open position and drainage ceases, a user may forget to administer a second actuation to actuate the valve back into the closed position, or assume that the valve has been actuated into the closed position while it still remains in the open position. Should the valve be left inadvertently in the open position, unexpected drainage will result.
In U.S. Pat. No. 3,939,821 and 4,024,855, magnetic valve members are implanted about the urethra of the user and require external actuating means to cause the valve to operate. Such devices necessitate surgical implantation of the magnetic valve members. Should operational problems occur in these devices, further surgery may be required.
It is thus desirable to provide a female incontinence control device that is magnetically actuatable by the user with a hand-held magnet to control urinary discharge, is relatively easy to use, does not unduly impede normal activity of the user and does not require surgical installation.